Deep Brain Therapy With Low-intensity Ultrasound for Treatment of Post-traumatic Stress Disorder
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- PTSD Checklist for DSM-5 (PCL-5)
研究概览
简要总结
This study will evaluate a new form of non-invasive deep brain therapy for individuals with post-traumatic stress disorder (PTSD). Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The trial will evaluate brain target engagement using magnetic resonance imaging and numerical scales of PTSD, cognitive performance, and mood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive PTSD diagnosis; PCL-5 > 20
排除标准
- •Inability to complete MRI
- •Suicidal ideation
结局指标
主要结局
PTSD Checklist for DSM-5 (PCL-5)
时间窗: Up to 3 months following study initiation
20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The total severity scores range from 0 to 80.
次要结局
- California Verbal Learning Test, 3rd Edition (CVLT3)(Up to 3 months following study initiation)
- National Institutes of Health Toolbox Cognitive Battery (NIHTB-CB)(Up to 3 months following study initiation)
- PROMIS scale of Pain Intensity(Up to 3 months following study initiation)
- Hamilton Depression Rating Scale (HDRS-17)(Up to 3 months following study initiation)
- Pittsburgh Sleep Quality Index (PSQI)(Up to 3 months following study initiation)
研究者
Jan Kubanek
Assistant Professor
University of Utah